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Cryotherapy and TENS on Low Back Pain (CTLBP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03248505
Recruitment Status : Unknown
Verified August 2017 by Jamilson Simões Brasileiro, Universidade Federal do Rio Grande do Norte.
Recruitment status was:  Recruiting
First Posted : August 14, 2017
Last Update Posted : August 14, 2017
Sponsor:
Information provided by (Responsible Party):
Jamilson Simões Brasileiro, Universidade Federal do Rio Grande do Norte

Tracking Information
First Submitted Date  ICMJE August 9, 2017
First Posted Date  ICMJE August 14, 2017
Last Update Posted Date August 14, 2017
Actual Study Start Date  ICMJE May 29, 2017
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 9, 2017)
Painful sensation [ Time Frame: Evaluation of pain sensation 25 minutes after the application of the intervention. ]
Pain sensation measured by pain numerical rating scale
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cryotherapy and TENS on Low Back Pain
Official Title  ICMJE Immediate Effects of Conventional TENS and Burst TENS Combined With Cryotherapy in the Non-specific Low Back Pain
Brief Summary

This study aim analyze the immediate effects of conventional transcutaneous electrical nerve stimulation (TENS) and Burst TENS combined or not with cryotherapy in patients with non-specific low back pain.

All subjects will be submitted to an evaluation of the painful sensation, through the numerical rating scale, and pain threshold, through algometry, before, immediately after the intervention and 25 minutes after.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
3x6
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Low Back Pain, Mechanical
Intervention  ICMJE
  • Device: Conventional TENS
    Transcutaneous Electrical Nerve Stimulation (frequency of 100 Hz, pulse duration of 100 micro-seconds and sensory-level amplitude) with two electrodes in each side of the lumbar spinal.
    Other Name: Transcutaneous Electrical Nerve Stimulation
  • Device: Burst TENS
    Burst-modulated TENS with carrier frequency of 100 Hz, burst-modulated at 4Hz, pulse duration of 200 micro-seconds and motor-level amplitude.
    Other Name: Burst-modulated TENS
  • Other: Cryotherapy
    1,5 Kg of crushed ice pack on lumbar spine.
    Other Name: Ice
  • Device: Burst TENS + Cryotherapy
    Burst-modulated TENS with carrier frequency of 100 Hz, burst-modulated at 4Hz, pulse duration of 200 micro-seconds and motor-level amplitude plus 1,5 Kg of crushed ice pack on lumbar spine.
    Other Name: Burst-modulated TENS and Ice
  • Device: Conventional TENS + Cryotherapy
    Transcutaneous Electrical Nerve Stimulation (frequency of 100 Hz, pulse duration of 100 micro-seconds and sensory-level amplitude) plus s 1,5 Kg of crushed ice pack on lumbar spine.
    Other Name: Transcutaneous Electrical Nerve Stimulation + Ice
  • Other: Placebo TENS
    TENS device turned on, but with zero amplitude.
    Other Name: Placebo
Study Arms  ICMJE
  • Placebo Comparator: Placebo TENS
    TENS unit turned on, but with zero amplitude.
    Intervention: Other: Placebo TENS
  • Experimental: Conventional TENS
    Symmetrical biphasic pulsed current, with frequency of 100 Hz, pulse duration of 100 micro-seconds and sensory-level amplitude.
    Intervention: Device: Conventional TENS
  • Experimental: Burst TENS
    Carrier frequency of 100 Hz burst-modulated at 4Hz, pulse duration of 200 micro-seconds and motor-level amplitude.
    Intervention: Device: Burst TENS
  • Experimental: Cryotherapy
    1,5 Kg crushed ice pack
    Intervention: Other: Cryotherapy
  • Experimental: Burst TENS + Cryotherapy
    Carrier frequency of 100 Hz burst-modulated at 4Hz, pulse duration of 200 micro-seconds and motor-level amplitude plus an ice pack of 1,5 Kg.
    Intervention: Device: Burst TENS + Cryotherapy
  • Experimental: Conventional TENS + Cryotherapy
    Symmetrical biphasic pulsed current, with frequency of 100 Hz, pulse duration of 100 micro-seconds and sensory-level amplitude plus an ice pack of 1,5 Kg.
    Intervention: Device: Conventional TENS + Cryotherapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 9, 2017)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2018
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Aged between 18 and 50 years;
  • Have chronic non-specific low back pain.

Exclusion Criteria:

  • Serious spinal pathologies (fractures, tumors, and inflammatory pathologies such as ankylosing spondylitis);
  • Nerve root compromise (disc herniation and spondylolisthesis with neurological compromise, spinal stenosis, and others);
  • Fibromyalgia
  • Corticosteroid treatment in the previous two weeks;
  • Antiinflammatory treatment in the previous 24 hours;
  • Contraindications to the use of Kinesio Taping (allergy or intolerance);
  • Score of three or less on Visual Analogue Scale of the first day;
  • Pregnancy;
  • Ice allergy.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03248505
Other Study ID Numbers  ICMJE TENS_LBP
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Jamilson Simões Brasileiro, Universidade Federal do Rio Grande do Norte
Study Sponsor  ICMJE Universidade Federal do Rio Grande do Norte
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Universidade Federal do Rio Grande do Norte
Verification Date August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP